NCT01850160

Brief Summary

This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of adult patients with diagnosis of arterial hypertension.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Apr 2013

Typical duration for phase_3 hypertension

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

May 7, 2013

Last Update Submit

January 25, 2016

Conditions

Hypertension

Keywords

HypertensionHigh blood pressureDrug therapy combinationValsartanChlorthalidoneSafetyEfficacy

Outcome Measures

Primary Outcomes (1)

  • Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone

    Efficacy and safety of a fixed-dose combination treatment of Valsartan plus Chlorthalidone Vs Valsartan or Chlorthalidone alone in the treatment of patients with arterial hypertension

    12 weeks

Secondary Outcomes (8)

  • Changes in Systolic and Diastolic Blood pressure values

    12 weeks

  • Changes of Systolic blood pressure values

    12 weeks

  • Changes of Diastolic blood pressure values

    12 weeks

  • Changes of diastolic blood pressure in arterial blood pressure median values

    12 weeks

  • Changes of systolic blood pressure values in arterial blood pressure median values

    12 weeks

  • +3 more secondary outcomes

Other Outcomes (2)

  • Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone

    12 weeks

  • Incidence of adverse events in each intervention group

    12 weeks

Study Arms (3)

GROUP A: Valsartan plus Chlorthalidone

EXPERIMENTAL

GROUP A: Combination therapy of Valsartan plus Chlorthalidone. Valsartan 80 mg/Chlorthalidone 12,5 mg. Once daily during 12 weeks.

Drug: GROUP A: Valsartan plus Chlorthalidone

GROUP B: Valsartan

EXPERIMENTAL

GROUP B: Treatment with Monotherapy. Valsartan 80 mg. Once daily during 12 weeks.

Drug: GROUP B: Valsartan

GROUP C: Chlorthalidone

EXPERIMENTAL

GROUP C: Treatment with Monotherapy. Chlorthalidone 12,5 mg. Once daily during 12 weeks.

Drug: GROUP C: Chlorthalidone

Interventions

GROUP A: Valsartan plus ChlorthalidoneDRUG

Combination therapy of Valsartan plus Chlorthalidone: Valsartan 80 mg / Chlorthalidone 12,5 mg. Once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg / Chlorthalidone 25 mg once daily.

Also known as: Chlorthalidone Drug Combination, Valsartan Drug Combination, Antihypertensive Agents
GROUP A: Valsartan plus Chlorthalidone
GROUP B: ValsartanDRUG

GROUP B: Treatment monotherapy: Valsartan 80 mg once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg once daily.

Also known as: Angiotensin II Receptor Antagonist, Antihypertensive Agents
GROUP B: Valsartan
GROUP C: ChlorthalidoneDRUG

GROUP C: Treatment monotherapy: Chlorthalidone 12,5 mg once daily during 12 weeks. If the goals of blood pressure are uncontrolled at week 6, the dose will be increase to Chlorthalidone 25 mg once daily.

Also known as: Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics
GROUP C: Chlorthalidone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with diagnosis of arterial hypertension defined as:
  • Systolic blood pressure greater or equal to 140 and lower than 180 mmHg
  • Diastolic blood pressure greater or equal to 90 and lower than 110 mmHg
  • Non controlled patients with antihypertensive treatment (blood pressure values: Systolic blood pressure \> 140 mmHg and/or Diastolic blood pressure \> 90 mmHg) or patients antihypertensive treatment-naïve.
  • Likelihood of attending consultations according to the trial chronogram.
  • Informed Consent Signature.

You may not qualify if:

  • Diagnosis of severe or malignant arterial hypertension defined as:
  • Systolic blood pressure greater or equal to 180 mmHg
  • Diastolic blood pressure greater or equal to 110 mmHg
  • Patients with secondary arterial hypertension of any etiology.
  • Pregnant women or women with childbearing potential who are not using appropriate contraception methods; women planning to become pregnant during the trial.
  • Patients with history of Acute Myocardial Infarction o Angina Pectoris within the 6 months prior to the trial initiation.
  • Diagnosis of Cerebrovascular Disease (CVD) o Transient Ischemic Attack (TIA) within the 6 previous months.
  • Patients with Severe Renal Disease defined by serum Creatinine levels higher than 1.5 mg/dl.
  • Diagnosed or suspected unilateral or bilateral renal artery stenosis.
  • History of non remitting cancer within the 5 years prior to the trial initiation.
  • Patients with Hypokalemia or Hyperkalemia.
  • Patients receiving Valsartan or Chlortalidone during the 14 previous days.
  • Patients with known hypersensitivity to Valsartan or Chlorthalidone.
  • Unstable patients with antecedent of hospitalization within the 4 days prior to their enrollment in the trial.
  • Patients with history of drugs and alcohol abuse within the last year.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

MedPlus

Bogota DC, Bogota DC, 11001, Colombia

Location

Centro de Diagnostico Cardiologico

Cartagena, Departamento de Bolívar, 130001, Colombia

Location

Fundacion Cardiomet Cequin

Armenia, Quindío Department, 630001, Colombia

Location

Centro AMCOR

Quito, EC170150, Ecuador

Location

Centro Clinico quirurgico

Quito, EC170150, Ecuador

Location

Centro médico de hipertensión arterial

Quito, EC170150, Ecuador

Location

Clínica DAME

Quito, EC170150, Ecuador

Location

Consultorio Edificio Novoa

Quito, EC170150, Ecuador

Location

Related Publications (1)

  • Manzur F, Rico A, Romero JD, Rodriguez-Martinez CE. Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study. Clin Med Insights Cardiol. 2018 Sep 3;12:1179546818796482. doi: 10.1177/1179546818796482. eCollection 2018.

    PMID: 30202211DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

ChlorthalidoneAntihypertensive AgentsAngiotensin Receptor AntagonistsSodium Chloride Symporter InhibitorsDiuretics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesMolecular Mechanisms of Pharmacological ActionMembrane Transport ModulatorsNatriuretic AgentsPhysiological Effects of Drugs

Study Officials

  • Juan D Romero, MD

    Farma de Colombia SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 9, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

January 26, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

CO(3)EC(5)